In the United States, obesity affects the health of 80 million adults, or 35 percent of the adult population, according to statistics from the Centers for Disease Control and Prevention. American children are also becoming increasingly affected by obesity, as 9 million, or 15 percent of the child population has fallen victim to this disease in recent years.
Morbidly obese individuals are identified as those where the disease of obesity has advanced to where the individual has a Body Mass Index (BM1) of over 40 or a BMI of over 35 along with other “co-morbidities” such as diabetes or high blood pressure. To reach a BMI of 35, a 5-foot-10-inch man or a 5-foot-4-inch woman would need to weigh 243 pounds and 204 pounds, respectively. For these individuals, dieting has often become a futile effort, as while some pounds may be shed, over time it has been found that these pounds are often quickly regained. Due to the health threats posed by their condition, morbidly obese individuals have turned to gastric bypass surgery in increasing numbers as an effective method to lose weight.
There are a number of methods of gastric bypass surgery, as well as a number of medical appliances which have been developed to assist in the application of these methods. However, most methods of gastric bypass surgery operate on the theme of creating a reduced-size “gastric” pouch” out of the stomach, which remains connected to the small intestine. The pouch restricts the amount of food entering the body to a fraction of what would normally enter an unrestricted stomach. Once the pouch is full, the patient often experiences the same feelings of fullness and satiety as would be experienced with an unrestricted stomach.
U.S. Pat. No. 5,771,903 issued to Jakobsson involves a method of gastric bypass surgery where the lower part of the esophagus is dissected and a band is applied around the lower part of the esophagus and an upper part of the stomach to form a small gastric pouch which upon filling with minimal food gives the patient a feeling of fullness or satiety. The band is inflatable and serves as a type of restrictor valve to regulate the amount of food passing from the banded upper gastric pouch to the unrestricted lower stomach. The band can be selectively inflated or deflated, depending upon the amount of food that is desired to be passed from the upper to lower stomach.
U.S. Pat. No. 6,572,627 issued to Gabbay discloses a system to inhibit the expansion of the stomach. The system involves placing a band about midway along the patient's stomach to create a restricted, smaller stomach. The system also employs a section of webbing that is placed around the upper half of the now restricted stomach. The webbing helps limit the expansion of the upper stomach.
Other inflatable band devices include the Lap Band™ System from Inamed Health of Santa Barbara, Calif.; the Heliogast™ gastric band from Helioscopie of Vienne Cedex, France; the Midband™ from Medical Innovation Development of Villeurbanne, France; and the Swedish Adjustable Gastric Band (SAGB) from Ethicon Endo-Surgery of the United States. These devices are placed around the stomach at its top or midpoint to create a smaller stomach.
The Proring® and Siliband® are gastric bands, both from Innovative Obesity Care of Saint Etienne, France, which require that the top of the stomach and esophagus first be stapled to form a small stomach pouch. The Proring® and Siliband® are then placed at the bottom of the pouch to form a restrictor valve for regulating the passage of food materials into the lower stomach. The Proring® has a closeable latch with a male-female engagement which is locked by the placement of a suture. The Siliband is closed and attached with sutures.
The prior art gastric band devices and their associated medical procedures have a success rate of about 65%, with many patients experiencing weight gain again after 5 years. Also, the following complications can result from existing devices and procedures.
First, the adjustable band devices can have a cross sectional contact width as large as 1″ which has been found to cause the leakage of pouch contents into the peritoneal cavity, should these devices erode into the gastric pouch. The body is unable to form scar tissue around, and seal off, such a wide band device. This erosion problem is serious in that some deaths have occurred, and in lesser cases, these prior art bands have had to be removed, or else additional surgeries were necessary to repair leakage problems.
Second, the adjustable band devices have a tendency to accidentally enlarge, thereby letting more food through the restricted area than desired, and causing weight gain to return.
Therefore, a need exists for a gastric bypass band which does not promote leakage of pouch contents into the peritoneal cavity and which further does not accidentally enlarge, thereby allowing weight gain to return.
The foregoing reflects the state of the art of which the inventor is aware, and is tendered with a view toward discharging the inventor's acknowledged duty of candor, which may be pertinent to the patentability of the present invention. It is respectfully stipulated, however, that the foregoing discussion does not teach or render obvious, singly or when considered in combination, the inventor's claimed invention.